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*
Division of Nephrology, Department of Medicine, New England Medical
Center, Boston, Massachusetts.
Division of Clinical Care Research, Department of Medicine, New England
Medical Center, Boston, Massachusetts.
Correspondence to Dr. Annamaria Kausz, Division of Nephrology, New England Medical Center, Box 391, Boston, MA 02111. Phone: 617-636-9424; Fax: 617-636-8329; E-mail: Akausz{at}lifespan.org
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Abstract |
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 Top Abstract IntroductionMaterials and MethodsResultsDiscussionReferences |
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1.5 mg/dl for women and 2.0 mg/dl for
men) were seen between October 1994 and September 1998 at five nephrology
outpatient clinics in the Boston area. The mean (SD) age of the patients was
63 (15.5) yr, and 53% were male. At the first nephrology visit, mean (SD)
serum creatinine was 3.2 (1.6) mg/dl, and mean (SD) predicted GFR was 22.3
(8.9) ml/min per 1.73 m2. Laboratory tests for iron levels were
performed in only 18% of patients, serum parathyroid hormone levels were
obtained in only 15%, lipid studies were obtained in fewer than half, and
among patients with diabetes, only 28% had a glycosylated hemoglobin level
measured. A hematocrit <30% was present in 38%, and abnormal
calcium-phosphorus metabolism was noted in 55%. Only 59% of patients who had
hematocrit <30% received recombinant human erythropoietin. Among patients
who received recombinant human erythropoietin, only 47% received iron.
Angiotensin-converting enzyme inhibitor use was recorded for only 65% of
patients with diabetes (49% of patients overall). Among patients who were
known to have progressed to ESRD, only 41% had permanent access placed before
initiation of dialysis. There seems to be room for improvement in the
management of patients with CRI, which could result in a slower rate of
progression of CRI and reduced severity of comorbid conditions. |
Introduction |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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1.7 mg/dl
and 0.8 million have serum creatinine levels 2.0 mg/dl
(7). Timely and optimal care
during CRI could modify the severity of comorbid conditions and the high
mortality among patients with ESRD. Furthermore, improved and timely care
during CRI possibly may improve the quality of life of patients with renal
insufficiency, reduce the incidence of ESRD, and reduce the cost of ESRD care
(8,9).
Thus, optimization of care during CRI could be the key to improved ESRD
outcomes. Although formal guidelines for care of the patient with CRI do not exist, few would argue that optimal care should involve early diagnosis of renal insufficiency and use of interventions to delay its progression, prevention or attenuation of the expected clinical and biochemical abnormalities of renal dysfunction, modification of comorbid conditions, adequate preparation for ESRD therapy, and timely initiation of dialysis. However, there is limited information on the patterns of testing of CRI patients for prevalence of complications of CRI and nonrenal comorbidity or the practice of the above-mentioned interventions. Hence, we performed a historical prospective cohort study to investigate the current status of care during CRI in the Greater Boston area.
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Materials and Methods |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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1.5 mg/dl for women and 2.0 mg/dl for men on at least two
occasions. Office records were reviewed for all patients who attended
outpatient nephrology clinics between October 1994 and September 1998.
Identification of patients with CRI in the New England Medical Center
nephrology clinic was done by reviewing the serum creatinine levels and
diagnoses of all patients identified as having a nephrology clinic visit by
query of the computerized utilization database. At the St. Elizabeth's Medical
Center and private nephrology practices, patients with CRI were identified by
manual review of the clinic records. Patients who were followed at more than
one of these sites were assigned to the site at which a majority of the care
was provided. The time of entry into the study was the first date that criteria for CRI were met for patients whose first visit to the clinic occurred after October 1, 1994. For patients with criteria for CRI who were followed earlier, October 1, 1994, was considered to be the date of entry into the study. Follow-up information was obtained until the start of dialysis, transplantation, transfer to another facility, end date of the study (September 1998), or death, whichever occurred earliest. Among patients who were followed in clinic before October 1, 1994, the first date of diagnosis of CRI and visit to the nephrologist were recorded if available.
Data Sources
Data were abstracted by three nephrologist investigators (R.A., W.K., and
S.K.) and entered directly into an electronic database designed for this
study. The data were obtained by review of the hospital and clinic charts of
all sites; the computerized laboratory databases of St. Elizabeth's Medical
Center and area nephrologists when available; and the computerized database
with information on hospitalizations, laboratory results, and other
hospital-based care of New England Medical Center.
Data Collection
The total number of patients seen in the outpatient clinics during the time
frame of the study was recorded for all sites. Among patients who were
identified as having CRI, data were collected at baseline and each subsequent
visit during the time frame of the study (between October 1, 1994, and
September 30, 1998). Baseline data included demographic (age, gender, and
race), socioeconomic (type of insurance, occupation, and education), and
clinical (cause of CRI, year of diagnosis, and comorbid conditions/index of
disease severity [IDS] score) information. The IDS score was obtained by
assigning one of four disease severity levels (from 0 = not present to 3 =
uncontrolled condition) to 20 different disease domains, and the global IDS
score was the maximum score assigned to any of the domains
(10). Data obtained at each
visit during the study period included laboratory test results, as recorded in
the chart or available in the laboratory database, such as blood urea
nitrogen, serum creatinine, albumin, bicarbonate, sodium, potassium, calcium,
phosphate, alkaline phosphates, intact parathyroid hormone (PTH), glucose,
glycosylated hemoglobin (HbA1C), cholesterol, low-density lipoprotein,
triglyceride, hematocrit (HCT), and hemoglobin and clinical data such as
systolic and diastolic BP and information on the medications/interventions,
such as recombinant human erythropoietin (rHuEPO), calcitriol, phosphate
binders, angiotensin-converting enzyme inhibitors (ACE-I), any other
antihypertensive, and lipid-lowering agent. In addition, dates of first
discussions regarding need for renal replacement therapy (RRT), modality
selection, access placement, and dialysis initiation were recorded. Duration
and causes of hospitalization were recorded when identified.
Definitions and Equations
It was decided a priori that ACE-I use was going to be considered
as prescribed for delaying the progression of renal insufficiency.
Hypertension (HTN) was defined as systolic BP >140 mmHg and/or diastolic BP
>90 mmHg on more than two occasions or non—ACE-I antihypertensive
medication use. Hypercholesterolemia was defined as serum cholesterol >200
mg/dl and/or lipid-lowering agent use. Hypoalbuminemia was defined as two or
more serum albumin levels <3.5 mg/dl. The method used to assay serum
albumin was not known at most of the sites. Anemia was defined as a HCT
<30%, before rHuEPO, if any use recorded. Abnormal calcium-phosphorus
metabolism was defined as a PTH level >100 pg/dl and/or a serum phosphorus
level >4.5 mg/dl or use of calcitriol and/or phosphate binder. Acidosis was
defined as serum bicarbonate level <20 mmol/L. Medication use was included
in the definitions for hypercholesterolemia and abnormal calcium-phosphorus
metabolism, because the assumption was made that if therapy was being used, at
some time the patient must have had a sufficiently abnormal laboratory value
to justify initiation of therapy. GFR in ml/min per 1.73 m2 was
predicted using the equation derived from the results of the Modification of
Diet in Renal Disease Study
(11): 170 x [serum
creatinine (mg/dl)]-0.999 x [age (yr)]-0.176
x [0.762 if female] x [1.18 if black] x [blood urea nitrogen
(mg/dl)]-0.17 x [albumin (g/dl)]+0.318.
Data Categorization
Age was categorized as 18 to 40, 41 to 64, 65 to 74, and >75 yr.
Patients were assigned to one of the following racial groups: white, black,
Asian, Hispanic, or other. The causes of CRI were classified as diabetes, HTN,
glomerulonephritis/interstitial nephritis/polycystic kidney disease, or other.
The principal type of insurance for each patient was recorded as health
maintenance organization (HMO), private (fee-for-service), Medicare, Medicaid,
or none. For patients with Medicare and either HMO or private insurance, type
of insurance was assigned to the latter.
Statistical Analyses
The proportion of patients with CRI who received outpatient follow-up in
the nephrology clinics during the time frame of the study was determined.
Descriptive statistics of demographic and clinical characteristics at baseline
were obtained. The serum creatinine and predicted GFR at the first nephrology
visit was determined overall and by patient characteristic. Descriptive
statistics and frequency distributions of continuous and categorical
variables, as appropriate, were obtained. The prevalence of anemia,
hypoalbuminemia, HTN, hypercholesterolemia, and abnormal calcium-phosphorus
metabolism, noted at any time during the study, was calculated. The prevalence
of each of these conditions also was calculated for each age, gender, race,
cause of CRI, and insurance category. The serum creatinine and predicted GFR
were determined at the initial diagnosis of the above-mentioned conditions,
first recorded institution of medications/interventions as listed above,
discussion relating to need for dialysis, access placement, and at last visit
before initiation of dialysis. When there was no laboratory value
corresponding to the date of diagnosis of the condition, the peak creatinine
closest to the time point within ±60 d was used for the
determination.
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Results |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Timing of First Visit to Nephrology
The first nephrology visit occurred, on average, when the serum creatinine
was 3.1 mg/dl and the GFR was 22.2 ml/min per 1.73 m2. The
distributions of serum creatinine levels and predicted GFR at the first
nephrology visit are presented in Figure
1. Renal function at first nephrology visit varied slightly by
patient demographic and clinical characteristic, but the differences were not
statistically significant (data not shown).
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Screening for Selected Conditions Associated with CRI
The prevalence of screening for conditions that are commonly associated
with CRI varied widely (Table
2). Most patients had HCT, serum calcium, and phosphorus levels
obtained at some time during the study. However, only 18% of patients had iron
studies, although 38% of patients had HCT <30% at some time during the
study. Only 15% had a serum PTH level documented at any time during follow-up.
Fewer than half of the patients had lipid levels recorded. Among patients with
the diagnosis of diabetes, only 28% had a HbA1C level either recorded in the
chart or available in the laboratory database.
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Prevalence of Selected Conditions Associated with CRI
Details of the prevalence of selected conditions overall and by demographic
characteristics and cause of CRI are presented in
Table 3. A total of 38% of the
patients had or developed severe anemia (HCT <30%) at some time during the
study. Patients with diabetes as cause of CRI had a higher prevalence of
anemia, compared with patients who had other causes of CRI (P <
0.05). Patients with private insurance had a lower prevalence of anemia (26%),
whereas patients with Medicaid had a higher prevalence of anemia (63%),
compared with patients with no (43%) or other (38 to 45%) types of insurance
(P < 0.05). Fifty-five percent of patients met criteria for
abnormal calcium-phosphorus metabolism. Patients of white and Asian race had a
lower prevalence of abnormal calcium-phosphorus metabolism than patients of
black and other races. Forty-two percent of patients had hypercholesterolemia
at some time during the study, and there were no significant differences by
patient characteristics (details not shown). Hypoalbuminemia was found among
22% of the patients. Patients with diabetes as cause of renal disease had the
highest prevalence of hypoalbuminemia (33%), and patients with other causes of
CRI had the lowest prevalence (7%; P < 0.05). The prevalence of
HTN was 97% (details not shown). Nineteen percent of the patients met criteria
for acidosis at some time during the study, with a higher prevalence of
acidosis among female patients (24%, compared with 15% among male patients;
P < 0.05).
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Management of CRI
ACE-I use was recorded for only 49% of patients overall. However, among
patients with diabetes either as a comorbid condition or as the cause of renal
disease, ACE-I use was recorded for 65%, compared with 39% among patients
without diabetes (P = 0.001). Eighty percent of the patients were on
a non—ACE-I antihypertensive medications. However, 65% of patients
overall had two or more BP recordings >140/90 mmHg. Among patients with
diabetes with a HbA1C level recorded, 55% had at least one level >7.5%
(details not shown).
Treatment of Selected Conditions among Affected Patients with
CRI
rHuEPO therapy at some time during the study was recorded for 20% of
patients overall, and 18% of patients received iron. Among patients who
received rHuEPO at some time during the study, 47% received iron, compared
with 10% among patients who never received rHuEPO. Among patients who
developed severe anemia (HCT <30%) at some time during the study, 59%
received rHuEPO. There were no significant differences in the prevalence of
use of rHuEPO by patient characteristics. However, a higher proportion of
anemic patients with private, HMO, or Medicare insurance tended to receive
rHuEPO (57 to 70%), compared with patients with Medicaid (42%) or no insurance
(33%). Eighteen percent of patients overall were on phosphate binders, and 15%
were on calcitriol. Among patients who met diagnostic criteria for abnormal
calcium-phosphorus metabolism, 60% were on some type of phosphate binder
and/or calcitriol. The prevalence of treatment for abnormal calcium-phosphorus
metabolism was higher among female patients and among patients with private
insurance (80%), compared with patients who had other types (58 to 64%) and no
(0%) insurance (P < 0.05).
Preparation for ESRD
The majority of patients had documentation of discussion regarding the need
for RRT for the first time at a predicted GFR <20 ml/min per 1.73
m2, and the mean predicted GFR at the first recorded discussion was
15 ml/min per 1.73 m2. Among the 103 patients who were known to
have progressed to the imminent need for RRT, 11% selected peritoneal
dialysis, 80% selected hemodialysis, 4% were to go on to transplantation, and
the outcome of the remainder could not be determined. Among these patients,
41% had permanent access placed before the initiation of dialysis. Among
patients who had planned access placement, this occurred at a mean of 157 d
before the initiation of RRT. The mean predicted GFR at planned permanent
access placement was 12.8 ± 4.9 ml/min per 1.73 m2 and did
not differ significantly on the basis of diabetic status or selected dialysis
modality.
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Discussion |
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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2 mg/dl and 6.2 million have serum creatinine
levels 1.5 mg/dl (7). The
Modification of Diet in Renal Disease Study demonstrated that renal function
declined progressively at an average rate of 4 ml/min per yr in the majority
of patients with GFR levels <55 ml/min per 1.73 m2
(12). Taking these two studies
together and that the U.S. population is aging
(13), it can be predicted that
the ESRD population will continue to increase in the future. The CRI
population already under the care of physicians can be most readily targeted
for interventions to improve the outcomes of patients with CRI and ESRD and
reduce the costs associated with ESRD care. The prevalence of CRI in the nephrology practices was 17%. The age and gender distribution of the CRI patients in this study was similar to that of patients starting ESRD therapy in the United States. The prevalence of HTN as the cause of CRI also was similar to the prevalence of HTN as the cause of ESRD in the United States. However, only 28% of the patients had diabetes as the cause of CRI, compared with 44% of patients starting ESRD therapy in the United States in 1997 (1). The mean serum creatinine and predicted GFR at the first nephrology visit were 3.1 mg/dl and 22.2 ml/min per 1.73 m2, respectively. To our knowledge, the only published recommendation to date regarding timing of nephrology referral is the NIH 1994 Consensus Statement on Morbidity and Mortality of Dialysis, which suggests referral to a nephrology team when the serum creatinine is >1.5 mg/dl for women and >2.0 mg/dl for men (14). However, the creatinine level at which a nephrologist should first become involved in the care of patients with renal dysfunction is a hotly debated issue. Nevertheless, it is becoming increasingly clear that complications of CRI, such as hypoalbuminemia, abnormalities of calcium-phosphorus metabolism, and cardiovascular disease, begin early in the course of disease and are progressive in nature (15,16,17,18). Indeed, we found that 38% of patients had severe anemia (HCT <30%) during the study, and, among patients who were screened, 55% had or were treated for abnormalities of calcium-phosphorus metabolism, 42% had hypercholesterolemia, 22% had hypoalbuminemia, and 19% had acidosis at some time during the study.
An important aspect of care during CRI is the implementation of interventions to slow the progression of renal disease. ACE-I use has been demonstrated to retard the progression of renal failure among patients with diabetes, and this probably is true among individuals without diabetes as well (19,20). Clinical trials also have demonstrated that BP control, glycemic control among patients with diabetes, and perhaps dietary protein restriction retard the development and progression of renal insufficiency (21,22,23). In the current study, only 49% of patients were found to be on ACE-I at some point during the study follow-up. In particular, among patients with diabetes, only 65% were on ACE-I. This is despite unequivocal evidence that ACE-I slows the progression of CRI (19,24,25) and the National Kidney Foundation's published recommendations for use of ACE-I among patients with diabetes mellitus who have microalbuminuria (26). The low rate of use of ACE-I among patients who are at risk has been reported in other situations. In a study of hospitalized Medicare patients in Atlanta, McClellan et al. (27) found that <35% of patients with diabetes and HTN with renal insufficiency had been prescribed ACE-I at discharge. Sixty-five percent of the patients in the current study were hypertensive, with two or more BP above the target level of 140/90 mmHg recommended in the fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High BP in 1993 (28). Among patients with diabetes, only 28% had a record of a HbA1C level to monitor adequacy of glycemic control. The results of this study suggest that impressive results from clinical trials on progression of CRI have not been translated fully into clinical practice, even in nephrology practices. However, it is possible that patients in whom a given intervention was not instituted may have had a contraindication for that therapy that was not captured in the data collection. It is also possible that an intervention recommended by the nephrologist may not have been implemented by the referring physician.
Optimal care during CRI includes prevention or attenuation of abnormalities and comorbid conditions associated with renal dysfunction. The majority of patients with progressive CRI invariably develop anemia, malnutrition, and abnormal calcium-phosphorus metabolism, and many have hyperlipidemia, all of which are associated with adverse outcomes among patients with ESRD (18,29,30,31,32,33,34,35,36,37). We found low rates of screening for many comorbid conditions or complications of uremia. Most patients had HCT, serum calcium, phosphorus, and albumin levels recorded, but very few had PTH and serum lipid levels recorded. It must be emphasized that these results may be underestimates, because only testing at the nephrology clinic or after referral to nephrology was captured. Nevertheless, failure to screen suggests lack of identification and treatment of conditions that contribute to increased morbidity among patients with renal failure. In our study, 38% of patients had HCT <30% at some time during the study, but, among these, only 59% received rHuEPO. This compares to a prevalence of HCT <30% of 67% and of rHuEPO use of 23% at initiation of dialysis previously described in the population of patients beginning ESRD therapy in the United States between 1995 and 1997 (38). It is important to note that the Health Care Financing Administration authorizes reimbursement for the use of rHuEPO for patients with renal insufficiency after the HCT falls below 30%, and many other third-party payers follow Health Care Financing Administration policy. Thus, lack of reimbursement for rHuEPO should not be a cause for failure to use rHuEPO when indicated. The prevalence of hypoalbuminemia in the study population was 23%, which compares to a 60% prevalence at initiation of dialysis among patients beginning ESRD therapy in the United States (38). These data demonstrate that the hypoalbuminemia observed among patients starting dialysis begins early during the course of CRI. The prevalence of abnormal calcium-phosphorus metabolism was 55%; among these patients, 60% received a phosphate binder and/or calcitriol. This study confirms that anemia, hypoalbuminemia, and abnormal calcium-phosphorus metabolism are prevalent early during the phase of CRI and that these conditions may require increased attention.
The final component of optimal care during CRI is adequate preparation for ESRD therapy and timely initiation of dialysis. Patients who are educated early regarding the need for RRT are more likely to choose peritoneal dialysis (4,8,39,40). In the current study, only 11% of patients selected peritoneal dialysis, possibly related to the late stage of renal failure at which the first discussion of the need for RRT occurred. However, it must be emphasized that a discussion may have occurred earlier but was not recorded. Timely access placement enables the initiation of dialysis without further procedures in an outpatient or nonemergent manner; thus results in lower use of resources in the initial phases of ESRD (41,42,43). Forty-one percent of the patients who were identified as having progressed to the imminent need for RRT had placement of permanent access before start of RRT, which compares to the rates of >50% for the Michigan (44) and United States (4). population. Last, only 4% of patients who were approaching ESRD were recorded as going on to transplantation, although it is known that patients who have transplants have improved quality of life. Further improvement in patient education, rates of placement of vascular access before the initiation of dialysis, and rates of transplantation are likely to promote a better quality of life for the patients and may result in reduced cost of ESRD care.
There are several limitations of this study, which relate mostly to the source of the patient population. First, the Greater Boston area has a very high penetrance of HMO, which may affect screening and referral practices; thus, the conclusions may not be readily generalized to the U.S. population with CRI. Second, the patient sample was derived from patients who were under the care of a nephrologist. Thus, the management practices of other physicians were not captured, and only the prevalence of CRI and its complications in nephrology practices was estimated, not that of CRI in the general population. Nonetheless, nephrology clinics are where patients with CRI are concentrated and hence are the ideal targets for strategies to improve management. Third, data were collected retrospectively; thus, there is great variability in the information and follow-up available on each patient. Notwithstanding these limitations, this report provides valuable information on a particular population that has not been well studied to date.
In summary, there is a relatively high prevalence of comorbid conditions among patients with CRI, and there seems to be room for improvement in the management of complications of CRI. An argument may be made that early interventions among patients with CRI could result in a slower rate of progression of renal insufficiency, reduction in the severity of renal and nonrenal comorbid conditions, smoother transition to ESRD, and possibly improved patient satisfaction. This ultimately could result in slowing the rate of rise in the incidence of ESRD; decline in the morbidity, mortality, and cost of ESRD care; and a better quality of life for patients. Evidence in support of the above could trigger significant changes in the practices of physicians who care for such patients and encourage third-party payers to commit resources toward early and comprehensive treatment of patients with CRI. The increased costs associated with early nephrology referral and intervention could be offset by reductions in the cost of ESRD care, in particular, the high cost in the first 6 mo of RRT. Future studies will be needed to accumulate evidence in support of the assumptions made above. Meanwhile, the nephrology clinic should be the first target for institution of care pathways to improve the clinical management of patients with CRI.
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Acknowledgments |
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This project was supported by the following grants from the National Institutes of Health: 1K08 DK 02745 (A.T.K.), T32 DK07777 (R.A.), and F32 HS 00143 (W.H.K.). The project also was supported in part by a grant from Amgen, Inc.
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